REACH: Making the compliance process foolproof for EU regulation

The European Chemicals Agency (ECHA), which was established on 1 June 2007, is at the centre of the regulatory system for chemicals in the European Union (EU), set out in Regulation (EC) No 1907/2006 of the European Parliament and the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). At the beginning of 2009, REACH was complemented by the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation (EC) No 1272/2008 of the European Parliament and the Council).
 
EU manufacturers, EU importers and Only Representative (of non-EU manufacturer) can only pre-register and register under REACH. The authorities in EU member states are responsible for the enforcement of REACH and CLP provisions. Both regulations invite severe penalties in case of non-compliance.
 
The REACH & CLP regulation has played an inspirational catalytic role in drafting and implementation of chemical regulation and GHS across the globe. Countries such as China, Turkey, Japan, Taiwan, South Korea, etc have recently adopted regulations on similar pattern and in some countries the regulation are in draft stages such as USA, India.
 
Therefore, it is important to have some basic knowledge about key processes and steps under REACH to help you minimise overall cost of regulatory compliances and plan right regulatory compliance strategy to exports their products globally.
 
Planning for become REACH-compliant
REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.
 
Especially with non-EU manufacturer the selection of Only Representative (OR) has to be done very carefully due to long-term work arrangement as majority of chemicals per entity falls under 2018 registration deadline and companies need to make decisions before the deadline to distribute cost of compliance under REACH. Companies must utilise this period to gather useful information in close cooperation with their service providers on how to minimise cost or find alternative ways for compliance (if exists).
 
Non-EU companies can export to the European Union through two different routes under REACH: either via an importer who has registered the substance, or by appointing an OR. Decision on relying on EU importers registration should be made after obtaining guidance from expert consultants, as most of the time EU importer (your customer) may not be in the position to disclose complete picture due to business advantage. Such decisions should be backed by documents to proof actual registration has taken place under REACH.
 
Advice for non-EU chemical companies

• Prior to exporting their substance to the EU, non-EU companies need to pre-register or register their substance with ECHA if the quantity of the substance exported into the EU exceeds 1 tonne per year;
• Non-EU companies who export their substance to the EU with the volume of the substance exceeding 1 tonne per year for the first time after 1^st December 2008 can submit a 'late pre-registration' for phase-in substances;
• Non-EU companies generally need to appoint an OR to submit (pre-) registrations to ECHA because only EU-based legal entities are allowed to register;
• Non-EU companies are obligated to inform their EU importers of the appointment of the OR;
• Non-EU companies are required to provide Safety Data Sheets (SDS) according to REACH and CLP standards (EU 453/2010) at the first delivery of a substance or preparation if the substances or preparations meet the criteria for classification as dangerous. Non-EU companies must provide on regular basis with updated SDS/e-SDS (if applicable) and export tonnage data along with details of EU customers to their OR;
• Companies also need to comply with CLP regulation;
• Meet your OR if you have not done so far and get basic understanding of REACH, check your substances status and plan strategy for compliance under REACH. This knowledge improves your business discussion with potential clients;
• Continuous check on substances: SVHC list, CoRAP list, authorisation list;
• Companies should keep all REACH exemption certificates with proper justification and supporting documents, simple declarations on company’s letter head sometimes may not work during audit process. Especially in case of polymer producers, they should keep relevant documents to confirm the product exported to EU is polymer under REACH along with analytical data supporting (GPC), complete composition details (in weightpercentages as determined in article 6.3 of REACH regulation), supplier’s REACH compliance declarations for monomers, solvents, etc should be valid;
• Non-EU companies may transfer OR if they are unhappy with the current OR
• Registration cost for companies under REACH is huge expense, and auditors sometimes like to know and understand whether these expenses are treated as ‘capital expenditure’ or ‘write off in revenue’. Such expenses can be treated as ‘intangible asset in the nature of a license fee’ as this gives you right to sell in EU market subject to fulfillment of prescribed conditions;
• In case majority of exports are linked to formulators (paints, inks, coatings, masterbatches, etc) it is advisable to run indirect exports project post REACH registration of those substances (used as major ingredient in the formulation). This may provide an opportunity to increase sales to non-EU customers (as formulators) taking advantage of compliance under REACH. Normally formulators (EU/non-EU) are looking for REACH compliant suppliers for their raw material requirement;
• After REACH Registration has been submitted by OR, please update your existing (M)SDS by inserting REACH Registration Number;
• After REACH registration please request your OR to provide you with Chemical Safety Report (CSR) and Guidance of Safe Use (GSU) if it is available as part of Letter of Access (LoA) package. CSR helps you to update your existing SDS/e-SDS (if applicable) and Labels, which in turn helps you to transfer good quality information on the safe use of chemicals in-house and in the supply chain.
• Please contact your OR to provide information on documents covering uses submitted as part of joint submission as this might give access to some new uses/applications which are still not explored.
• Companies complying under REACH & CLP should provide regular updates on regulatory compliances to sales & marketing team (eg, ISO 9001, ISO 14001, ISO 18001, EU REACH & CLP Certified firm). Companies should also consider updating their web pages answering relevant FAQ and obtain required guidance from OR to showcase your current compliance status.

 
(The second part of this series will provide some useful tips to SMEs for adhering to REACH regulation)
 
References:

• https://bsmedia.business-standard.comecha.europa.eu/  (ECHA, Finland)
• http://www.reachlaw.fi/ (REACHLaw, Finland)

 
The author is the Business Head – Regulatory Affairs, Dynamic Orbits Adviosry Pvt Ltd (the Indian interface of Finland-based REACHLaw), and a core member of a strategic committee formed by Chemexcil to draft ‘Indian chemical management program/Indian chemical inventory’.